GSK to market Merck’s Mevacor over-the-counter

PITTSBURGH What better way to try and get a statin sold as a nonprescription remedy than to sign on switch maverick GlaxoSmitthKline, the company that successfully switched complex OTC regimens associated with drugs like orlistat and smoking cessation products?

GlaxoSmithKline and Merck on Monday announced that they have entered into an agreement for the over-the-counter marketing rights for Mevacor. Under the agreement, GSK will have exclusive rights to market non-prescription Mevacor in the United States. Terms of the agreement are confidential but include milestone and royalty payments from GSK to Merck.

“This new partnership with Merck will enable GSK to address the important public health issue of high cholesterol and help patients better manage their health,” stated GSK chief executive officer JP Garnier. “OTC Mevacor will be a dynamic new addition to our fast-growing over-the-counter business and is further evidence of GSK’s ability to partner in new OTC switch opportunities.”

Merck had been planning to present to the Food and Drug Administration its justification to switch Mevacor OTC in December. It’s the third bite at the switch apple for Merck, this time without partner Johnson & Johnson. The companies will jointly seek approval of OTC Mevacor 20mg taken once daily to help lower cholesterol. OTC Mevacor 20mg is proposed for use in women age 55 and older and men age 45 and older with moderately elevated cholesterol and one or more heart disease risk factors.

Rite Aid locations in three West Coast states offer OTC genetic testing

Genetic testing is now available at the Rite Aid stores in California, Oregon and Washington, the New York Times has reported.

A company called Sorenson Genomics has started selling a paternity test kit in the chain’s stores on the West Coast. Reportedly, this is the first time a DNA test is being sold through a major pharmacy chain.

The infiltration of DNA testing into the pharmacy is another in the spread of genetic testing directly to consumers. Many genetic tests are already available directly to consumers through the Internet.

But Sorenson, whose slogan is “For questions only DNA can answer”, emphasizes the importance of satisfying such curiosities or medical issues that need to be addressed right away. “There is a curiosity and a need to know that can be provided discreetly, conveniently and affordably at retail,” said Douglas Fogg, chief operating officer of Sorenson Genomics.

The test, sold under the brand name Identigene, has a suggested list price of $29.99, though a Times reporter purchased one at a Rite Aid in Santa Monica, Calif., for $19.99. There is an additional laboratory fee of $119 to have the samples analyzed.

Genetic testing, some experts argue, may incomprehensible to consumers who have not received genetic counseling. ”Just because something’s available does not mean it’s safe or effective or worth your money,” said Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University.

Hudson added that most genetic tests available directly to consumers had not been reviewed by the Food and Drug Administration.

Still, drugstores already sell various non-DNA diagnostic tests, including those for pregnancy, drug use, cholesterol, blood sugar and H.I.V. When some of these were introduced there was also controversy about whether consumers could perform the tests or understand the results themselves, the Times said.

The results of a paternity test, unlike some of the medical tests, are pretty easy to understand. Sorenson said the test was designed for peace of mind, and that the results would probably not stand up in court because questions could be raised about whose samples were submitted.

The kit advises people wanting to test for legal purposes to call the company and set up a chain of custody for the samples, which would cost an additional $200.

Sorenson’s Fogg said the company sells about 1,500 to 2,000 paternity tests per month through the Internet and expressed hope to increase that greatly through sales at drugstores. Ashley Flower, a spokeswoman for Rite Aid, would not comment other than to confirm that the kit was being sold in the three West Coast states.

Sorenson, which is bankrolled by a medical device entrepreneur, James LeVoy Sorenson, also offers ancestry testing. Those tests, however, may not be offered at Rite Aid.

FDA approves Zyrtec for non-prescription use

FT. WASHINGTON, Pa. McNeil Consumer Healthcare on Friday received approval from the Food and Drug Administration for its allergy treatment Zyrtec (cetirizine HCl) to be used without a prescription for adults and children.

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